JP2008513155A - Thin film medical devices and delivery systems - Google Patents

Abstract

There is a need for a medical device that can occlude various portions of a blood vessel that are expected to have a narrow diameter and delivery profile.
The present invention relates to an internal lumen thin film medical device (100), particularly a medical device suitable for occlusion of an aneurysm, occlusion of a side vessel of a vessel, or dissociation of a body lumen or tube such as an artery or vein About. The medical device has a thin film tube (101) that extends longitudinally to a smaller peripheral contour by the supply of mechanical energy and releases the mechanical energy prior to stretching. It is possible to self-expand to length and diameter. To assist the membrane during expansion, a plurality of slots (102) are cut into the wall of the tube. The slot opens and assists in extending the membrane tube in the longitudinal direction and substantially closes when the membrane tube self-expands to its pre-extension length and diameter.
[Selection] Figure 1A

Description

Disclosure details

(Field of the Invention)
The present invention relates to thin film medical devices, and more particularly to intraluminal thin film medical devices and delivery systems. This medical device and delivery system is particularly suitable for aneurysm occlusion, vascular side branch occlusion, or dissociation of a body cavity or duct such as an artery or vein.

BACKGROUND OF THE INVENTION
There are many cases where it is desirable to permanently occlude blood vessels in the human body. Permanent occlusion of blood vessels is preferable for aneurysm or side branch vessel occlusion, therapeutic occlusion or embolization of the renal artery, occlusion of a Blalock-Taussig Shunt, pulmonary arteriovenous fistula And occlusion of transjugular intrahepatic stent shunt, some non-vascular procedures such as therapeutic ureteral obstruction, and occlusion of blood vessels leading to large cancerous tumors.

  To date, certain coil stents, stent grafts or separable balloons have been used to provide permanent occlusion of blood vessels. Stent grafts are essentially applied to either or both of the luminal and nonluminal surfaces of the stent that occlude open spaces or gaps between adjacent structural members of the endoluminal stent. An intraluminal stent comprising a discrete cover provided. Techniques for forming a stent graft by covering a stent using a synthetic material such as a woven polyester known as an endogenous vein or DACRON, or expanded polytetrafluoroethylene have been known. It has been. Also known is the prior art of covering the stent with a biocompatible material such as xenograft or collagen.

  Certain problems exist with coil stents, such as movement of a coil stent within a vessel to be occluded, perforation of the vessel by the coil stent, and the inability to completely thrombose or occlude the vessel. Another drawback with such coil stents is that the blood vessels cannot be occluded immediately after placement in the blood vessel. Disadvantages with separable occlusion balloons include premature detachment between distal emboli or occlusions, and this instrument is used to learn the proper use of such separable occlusion balloons. Users are believed to require longer time.

  In addition to vascular occlusion, conventional graft-type internal luminal medical devices are frequently used to reduce vascular structure support after angioplasty and the occurrence of restenosis after angioplasty with a percutaneous balloon. The A major example is an intravascular stent that is introduced from a site of introduction remote from a diseased or damaged site to a diseased or damaged site in the body's vascular system using a guide catheter, The diseased or damaged site is guided from the guide catheter so as to be passed through a blood vessel that circulates between the remote introduction location and the diseased or damaged site, and to maintain the open state of the blood vessel at the diseased or damaged site. Released. Stent grafts are delivered and deployed in a similar environment, for example, by reducing restenosis after angioplasty or when used to resect aneurysms, such as in aortic aneurysm resection procedures. It is used to maintain a common passage.

  When these medical devices have particular problems, their outer dimensions such as their diameter and delivery profile, in particular, become a significant drawback that makes specific use of these devices impossible. Another significant drawback is the limited flexibility that these instruments have because of the narrow and / or tortuous guide passages through the blood vessels. Accordingly, these medical devices are not preferred for many narrow diameter vascular applications such as neurovascular.

  Thus, there is a need for medical devices that can occlude various portions of blood vessels that are expected to have narrow diameters and delivery profiles.

[Summary of the Invention]
The present invention relates to an internal lumen thin film medical device particularly suitable for occlusion of an aneurysm, occlusion of a side branch of a blood vessel, or dissociation of a body lumen or duct such as an artery or vein. In certain embodiments of the present invention, a medical device comprises a thin film tube that can be extended longitudinally to provide a smaller peripheral profile by applying mechanical energy. Once the mechanical energy is released, the membrane tube can self-expand to the length and diameter before stretching. The medical device further comprises a plurality of slots carved in the wall of the thin film tube. The slot opens to assist the membrane tube in the longitudinal direction and closes substantially as the membrane tube self-expands to the length and diameter prior to extension.

  In another embodiment of the present invention, a medical device for occluding a body lumen includes a thin film tube that is longitudinally oriented to provide a smaller peripheral contour by applying mechanical energy. When stretched and mechanical energy is released, it is possible to self-expand to the length and diameter prior to stretching. A plurality of holes are carved into the wall of the membrane tube to assist in extending the membrane tube in the longitudinal direction.

  In yet another embodiment of the present invention, a medical device for occluding a body lumen comprises a membrane tube that is longitudinally oriented to provide a smaller peripheral contour by providing mechanical energy. When stretched to release mechanical energy, it is possible to self-expand to the length and diameter prior to stretching. The medical device further comprises a stent attached to the inner surface of the metal film.

  The present invention discloses a thin film medical device, in particular, suitable for occlusion of an aneurysm or side branch of a blood vessel, or dissociation of a body lumen or duct such as an artery or vein. One of the advantages of the present invention is to provide a biocompatible graft material that enables delivery of a minimally invasive medical device to a vascular site to occlude the blood flow while allowing blood to flow through the main blood vessel at the implantation site. It is to be.

  Although this specification provides a detailed description for the implantation of medical devices in arteries or veins, those skilled in the art will recognize that modifications of the disclosed invention can also be made, for example, cardiovascular, lymph gland, endocrine gland, kidney, gastrointestinal It will be appreciated that it is suitable for use in other body lumens and anatomical passages, such as and / or reproductive organs.

  The main component of the present invention is a thin film mainly formed of a substantially self-supporting biocompatible metal or psuedometal. The thin film can be formed as either a single layer or multiple layers. The terms “thin film”, “metal film”, “thin metal film” and “metal film” are more than 0.1 μm and less than 250 μm, preferably between 1 μm and 50 μm biocompatible metal or biocompatible Are used synonymously in this application to refer to single or multi-layer films formed of different pseudometals. In some specific embodiments of the present invention where the thin film is used as a structural support element, the thin film may be thicker than about 25 μm. In other embodiments, for example, where the thin film is used as a cover member with additional structural support, the thickness of the thin film is between about 0.1 μm and 30 μm, most preferably 0.1 μm. Between 10 μm and 10 μm.

  In a preferred embodiment, the medical device is formed of a thin shape memory or pseudo metal film having superelastic properties and shape memory. An example of a shape memory metal thin film is nickel titanium (Nitinol) formed in a tubular structure.

  Nitinol has a wide range of applications and includes medical device applications as described above. Nitinol or nickel titanium alloy has biomechanical compatibility, biocompatibility, fatigue resistance, torsional resistance, integral plastic deformation, nuclear magnetic resonance imaging compatibility, characteristics that exert a certain static pressure to the outside, Widely used in the formation or construction of medical devices for a number of reasons including mechanical interference, thermal expansion properties, elastic expansion properties, hysteresis properties, and moderate radiopacity.

  As described above, nitinol exhibits shape memory properties and / or superelastic properties. The shape memory characteristics will be described in a simplified manner below. For example, the metal structure of a nitinol tube in the austenite phase can be cooled to the temperature in the martensite phase. Once in the martensite phase, the Nitinol tube is deformed into a specific structure or shape by applying stress. As long as the nitinol tube is maintained in the martensite phase, the nitinol tube retains its deformed shape. If the Nitinol tube is heated to a temperature sufficient to enter the austenite phase, the Nitinol tube will return to its original or programmed shape. The original shape is programmed to a specific shape by well-known techniques as described in the simple description above.

  The superelastic property can be simply explained as follows. For example, the metal structure of a nitinol tube in the austenite phase is transformed into a specific structure or shape by applying mechanical energy. This mechanical energy application causes deformation of the martensite phase due to stress. That is, the nitinol tube can change from the austenite phase to the martensite phase by mechanical energy. Using appropriate measuring equipment, it is measured that stress from mechanical energy causes a temperature drop in the Nitinol tube. When mechanical energy or stress is released, the Nitinol tube returns to the original austenite phase of the other mechanical phase and assumes the original or programmed shape. As described above, the original shape is programmed by well-known techniques. Martensite and austenite phases are common phases in many metals.

  Medical devices composed of nitinol are typically utilized in both the martensite phase and / or the austenite phase. The martensite phase is a phase at a low temperature. The material in the martensite phase is usually very soft and malleable. Nitinol is easy to form or compose in a complex or complex structure due to these properties. The austenite phase is a phase at high temperature. Materials in the austenite phase are usually much stronger than materials in the martensite phase. In general, many medical devices are cooled to the martensite phase for introduction into the handling and delivery system. The device returns to the austenite phase when deployed at body temperature.

  Nitinol is illustrated in this example, but should not be understood as limiting the scope of the invention. One skilled in the art will appreciate that both other materials, metals and pseudometals that exhibit similar shape memory properties, and superelastic properties can be used.

  The tube-like membrane structure is sized to fit or slightly larger than the diameter of the internal lumen of the body vessel when the tube is in an unrestrained (self-expanding) shape Is done. This inherent property of thin Nitinol tubes allows the tubes to be stretched longitudinally to reduce the tube diameter. The reduced diameter allows the medical device to maintain a small profile for insertion into the body lumen via the catheter during percutaneous internal lumen procedures. Thus, due to the inherent shape memory and superelastic properties, a thin metal tube can be stretched and constrained to a reduced profile shape, and then when this suppression is removed, the original “pre-expansion” Can expand back to self-expanding diameter. As the tube diameter increases, it contracts or shortens in the longitudinal direction to the length and diameter prior to expansion.

  1A and 1B show a medical device according to an embodiment of the present invention formed from a Nitinol thin film tube. FIG. 1A shows the thin film medical device 100 in a deployed or “pre-expanded” configuration, and FIG. 1B shows the thin film medical device 100 in a stretched and reduced profile and in a restrained state.

  To facilitate the longitudinal extension of the thin film medical device 100, the tube structure 101 has a plurality of radial slots 102 engraved or formed around its wall. In one embodiment, the slot has a slit shape formed entirely on the wall of the thin-film tube 101. Also, with the thin film formed in layers, the radial slot 102 will be opened in one or more layers of the wall of the thin film tube 101. When the thin-film tube 101 is elongated in the vertical direction, the slot 102 is opened, and an opening is formed in the wall of the tube 101. When the membrane tube 101 returns to its pre-expansion (radial expansion) shape, the radial slot 102 is closed and stops blood flow in the circumferential direction.

  The terms “exclude”, “excluding” and variations thereof should not be construed as having zero porosity and completely blocking fluid flow. Rather, closed slits and apertures in the membrane that stop fluid flow have openings that are small enough to substantially stop blood flowing through the wall of the membrane tube 101. Also good. A medical device 100 showing all the radial slots 102 in the open position is shown in FIG. 1B.

  The medical device 100 can also be designed such that some of the radial slots 102 are open and other radial slots 102 remain substantially closed. FIG. 1C shows the medical device 100 with only a portion of the radial slot 102 along the proximal end 103 and the distal end 104 open, while the other radial slot 102 at the intermediate site remains closed. Show.

  In other embodiments of the present invention, the medical device 100 may also include variously shaped holes 102 cut or formed in the wall of the tube. The shape can be selected to facilitate longitudinal stretching and / or radial expansion of the membrane tube. In principle, the thin film holes 102 have longitudinal and lateral dimensions, thereby forming openings in the thin film having a net free open area.

  In order to stop the blood flow, the medical device 100 can be used over, for example, each site of an aneurysm, a side branch blood vessel, or a blood vessel wall abnormality. In one embodiment of the present invention, the tubular thin film 101 can be formed to have a thickness that can be supported by itself. Also, if additional radial support is required, the thinner film can be supported by a balloon or a self-expanding stent or multiple stents.

  FIG. 2 is a partial cross-sectional perspective view showing a medical device 200 deployed in a blood vessel 205 in one embodiment of the present invention. The blood vessel 205 has a weak vessel wall that has created an aneurysm 206 and a medical device 200 is deployed covering the aneurysm 206. The medical device 200 is self-supporting and does not require an additional stent for support. As described above, the medical device 200 includes a thin metal film tube 201 having a proximal end 203 and a distal end 204. The membrane tube 201 has a series of radial slots 202 arranged around the longitudinal axis of the membrane tube 201. When deployed from the catheter system, the radial slot 202 carved into the membrane tube 201 is substantially closed, stopping blood flow in the peripheral direction. This relieves pressure at the aneurysm 206 and subsides the potential pathology associated with the rupture of the aneurysm 206. By reducing the pressure in the aneurysm 206, the wall of the blood vessel 205 can be reduced.

  The medical device may also include one or more stents to assist in securing the thin film tube to the body wall. FIG. 3A shows a medical device 300 according to another embodiment of the present invention deployed throughout the aneurysm 306 of the vessel wall 305. Similar to the medical device described above, the medical device 300 comprises a thin metal film having a proximal end 303 and a distal end 304 formed in the tube 301. The membrane tube 301 has a series of radial slots 302 carved around it through the wall of the tube 301. The medical device 300 supplementarily includes a stent 307 along the proximal end 303.

  Stent 307 includes at least one hoop structure that extends between proximal end 303 and distal end 304 of stent 307, respectively. The hoop structure includes a plurality of strut members arranged in the vertical direction and a plurality of loop members connecting adjacent struts. Adjacent struts are connected to opposite ends in a substantially S or Z-shaped sinusoid pattern to form a plurality of cells. However, those skilled in the art will recognize that this pattern shaped by the struts is not a limiting factor, and other shaped patterns or radially expandable structures can be used.

  As described above, the stent 307 assists in securing the medical device 300 to the vessel wall 305. The thin film tube 301 may be secured to the stent 307 at anchor points 308. The attachment may be due to adhesion resulting from the radial pressure of the stent 307 against the thin metal membrane tube 301, bonding material, thermal or chemical bonding, and / or between the stent 307 and the thin metal membrane tube 301. Any suitable means may be used including adhesion by mechanical means such as solder or stitching. It should be noted that the stent 307 need not be fixedly attached to the metal membrane tube 301. Alternatively, the radially outward force that the stent 307 exerts on the vessel wall may be sufficient to hold the metal film 301 in place.

  In another embodiment, the thin metal membrane tube 301 can be secured to the wall of the blood vessel 305 with multiple anchors. FIG. 3B shows a proximal stent 307 with the membrane tube 301 attached to the wall of the blood vessel 305 along the proximal end 303 and a distal end of the membrane tube 301 attached to the wall of the blood vessel 305 along the distal end 304. A medical device 300 having a distal stent 309 is shown. One skilled in the art will note that an additional stent secures the medical device 300 to the wall of the blood vessel 305, such as an additional proximal or distal anchor disposed longitudinally along the membrane tube 301. It will be understood that it can be used for

  In yet another embodiment, a stent having multiple or longer hoop structures is used to fully support a thin metal film along the length of all or substantially all of the film. May be. FIG. 3C shows a medical device 300 having a plurality of hoop stents 307 that support the metal film 301 along the entire length of the substantially thin metal film.

  The multiple hoop stent 307 shown in FIG. 3C includes three hoop structures 311A-311C connected by a plurality of bridge members 314. Each bridge member 314 includes two ends 316A and 316B, with one end 316A and 316B of each bridge 314 attached to one hoop. Using the hoop portions 311A and 311B, for example, each bridge member 314 is connected to the proximal end of the hoop portion 311A at the end portion 316A and connected to the distal end of the hoop portion 311B at the end portion 316B.

  Various embodiments of the medical device described above are deployed after being delivered to the target area by the catheter system. FIG. 4 is a longitudinal cross-sectional view illustrating a medical device 400 according to an embodiment of the present invention having a self-supporting metal membrane tube 401 loaded into a delivery catheter 420. Catheter 420 includes an outer sheath 421 and an inner lumen 422. The outer sheath 421 serves to hold the thin film tube 401 in a state of being elongated in the vertical direction. The inner lumen 422 is substantially coaxial with the outer sheath 421 to provide a conduit for the guidewire.

  The medical device 400 is loaded into the delivery catheter 420 for deployment. A guide wire (not shown) is guided to the target area by known means, and the delivery catheter 420 / medical device 400 is loaded onto the guide wire using the internal lumen 422. The catheter 420 / medical device 400 is then pushed over the guidewire to the target site. Once properly positioned, the outer sheath 421 can be retracted and the membrane tube 401 can be expanded and shortened longitudinally to an unconstrained diameter. As described above, this causes the slot 402 (not shown) inscribed in the wall of the membrane tube 401 to be substantially closed, stopping blood flow to the vessel wall defect.

  The illustrated embodiment describes a wire delivery catheter. However, those skilled in the art will appreciate that other types of delivery catheters can be used, including catheters that utilize the monorail format as a known technique.

  As previously mentioned, very thin membranes may require additional radial support to properly secure the membrane within the vessel. In one example, the additional radial support can be provided by a radially expandable instrument, such as a radially expandable stent. FIG. 5 is a longitudinal cross-sectional view illustrating a medical device 500 having a self-expanding stent 507 for additional radial support according to an embodiment of the present invention.

  A catheter 520 for constrained delivery of a medical device 500 having a self-expanding stent 507 has three main parts. Similar to the embodiment described above, the catheter 520 includes an outer sheath 521 that serves to hold the membrane tube 501 in an elongated state. A smaller diameter second sheath 523, which serves to hold the self-expanding stent in a constrained state, is coaxial with the outer sheath 521. As described above, the medical device 500 can include one or more stents that add radial support, ie, stents 507 and 509 (not shown) as described above. In each case, the second sheath 523 serves to hold each radially expandable stent in a restrained state.

  The third component of the medical device 500 is an internal lumen 522. Inner lumen 522 is substantially coaxial with outer sheath 521 and second sheath 523 and provides a passage for the guidewire. The thin film tube 501 is fixed to the stent 507 at an anchor point 508. As noted above, attachment may be by any suitable means of attachment, including adhesion, bonding material, heat, or chemical resulting from the radial pressure of the stent 507 against the thin metal membrane tube 501. Adhesion by bonding and / or adhesion by mechanical means such as solder or stitching between the stent 507 and the thin metal film tube 501.

  The medical device 500 is loaded into the delivery catheter 520 for deployment. A guide wire (not shown) is guided to the target area by known means, and the delivery catheter 520 / medical device 500 is loaded onto the guide wire using the internal lumen 522. Alternatively, delivery catheter 520 / medical device 500 may be loaded onto the guidewire in a monorail format as known in the prior art. Delivery catheter 520 / medical device 500 is then pushed to the target site with a guidewire. Once properly positioned, the outer sheath 521 can be retracted and the membrane tube 501 can be expanded and shortened longitudinally to an unconstrained diameter. As described above, this causes the slot 502 (not shown) inscribed in the wall of the membrane tube 501 to be substantially closed, stopping blood flow to the vessel wall defect. The second sheath 523 is then retracted and the stent 507 and any other stent (not shown) can self-expand against the vessel wall (not shown). The radial pressure on the vessel wall created by the stent 507 secures the stent 507 in place. As a result, the thin film tube 501 is further supported and fixed to the blood vessel wall.

  In another example, a self-expanding stent may be replaced with a balloon expandable stent. FIG. 6 is a longitudinal cross-sectional view illustrating a medical device 600 in an embodiment of the present invention having a balloon expandable stent 607 for additional radial support.

  A catheter 620 for constrained delivery of a medical device 600 having a balloon expandable stent 607 comprises three main parts. Similar to the embodiment described above, the catheter 620 includes an outer sheath 621 that serves to hold the membrane tube 601 in an elongated state. The outer sheath 621 is coaxial with a balloon catheter 625 equipped with a balloon 624. Balloon expandable stent 607 is attached or fastened to balloon catheter 625 on dilatation balloon 624 with a low profile shape. As mentioned above, the medical device 600 can have one or more stents that add radial support, ie, stents 607 and 609 (not shown) as described above, and other possible other Things may be provided. In each case, the individual balloon 624 or multiple balloons 624 on the balloon catheter 625 can serve to hold and deliver the respective radially expandable stent in a constrained state.

  The third component of the medical device 600 is an internal lumen 622. The inner lumen 622 is substantially coaxial with the outer sheath 621 and balloon catheter 625 and provides a passage for the guidewire. In the preferred embodiment, the inner lumen 622 is an integral part of the balloon catheter 625. Alternatively, the catheter 620 may be a loop or similar capture device along the distal end for receiving a monorail style guidewire. Monorail type catheters are known in the prior art.

  Thin film tube 601 is preferably attached to stent 607 at anchor point 608. As described above, the attachment may be any suitable attachment means, including adhesion, bonding material, heat, or chemical resulting from the radial pressure of the stent 607 against the thin metal membrane tube 601. Adhesion by bonding and / or adhesion by mechanical means such as solder or stitching between the stent 607 and the thin metal film tube 601.

  Medical device 600 is attached to balloon catheter 625 for deployment. A guide wire (not shown) is guided to the target area by known means, and the balloon catheter 625 / medical device 600 is loaded onto the guide wire using the internal lumen 622. The balloon catheter 625 / medical device 600 is then pushed to the target site with a guide wire. Once properly positioned, the outer sheath 621 can be retracted and the membrane tube 601 can be expanded and shortened longitudinally to an unconstrained diameter. As described above, this causes a slot 602 (not shown) inscribed in the wall of the membrane tube 601 to close and stop blood flow to the vessel wall defect. Balloon 624 is then inflated (expanded) to expand stent 607 and all other stents (not shown) into the vessel wall (not shown). The radial pressure on the vessel wall created by the stent 607 locks the stent 607 in place. As a result, the thin film tube 601 is further supported and fixed to the blood vessel wall.

  While numerous variations of the invention have been shown and described in detail, other modifications and methods contemplated within the scope of the present invention will be readily apparent to those skilled in the art based on this disclosure. Various combinations or substitutions of combinations in particular embodiments may be made and are within the scope of the present invention. In addition, all the described components are intended to treat other blood vessels or lumens in the body, particularly in other body parts where there is a need to stop or regulate blood flow in the blood vessels or lumens in the body. It is considered beneficial to change. This includes, for example, coronary, vascular, non-vascular and surrounding blood vessels and ducts. Accordingly, it should be understood that various applications, modifications and alternatives are equivalent without departing from the spirit of the invention or the appended claims.

  The accompanying claims are provided to illustrate some useful features of the subject matter disclosed herein within the scope of the present invention.

Embodiment
(1) In a medical device for occluding a body vessel,
A thin-film tube that stretches longitudinally to give a smaller circumferential profile by applying mechanical energy and releases the mechanical energy to the length and diameter before stretching A self-expandable, thin-film tube,
A plurality of slots carved into the wall of the membrane tube that open to assist in extending the membrane tube in a longitudinal direction, the membrane tube being self-extending in length and diameter A slot that closes substantially when expanded, and
A medical device equipped with.
(2) In the medical instrument according to Embodiment 1,
The thin film tube is a medical instrument formed of a metal thin film exhibiting superelastic characteristics.
(3) In the medical instrument according to embodiment 2,
The metal thin film is a medical instrument formed of a nickel titanium alloy.
(4) In the medical instrument according to embodiment 1,
The thin film tube is a medical device formed of a psuedometallic thin film exhibiting superelastic properties.
(5) In the medical instrument according to embodiment 1,
The thin-film tube is a medical device that is self-supporting.
(6) In the medical instrument according to embodiment 1,
The thin film tube is a medical device formed as a single layer material.
(7) In the medical instrument according to Embodiment 1,
The thin-film tube is a medical device formed as a multilayer material.
(8) In the medical instrument according to embodiment 1,
The medical instrument, wherein the slot is engraved completely through the wall thickness of the tube.
(9) In the medical instrument according to Embodiment 1,
The medical instrument, wherein the slot is engraved partially through the wall thickness of the tube.
(10) In the medical instrument according to embodiment 1,
A plurality of holes provided in the wall of the tube,
A medical instrument further comprising:

(11) In the medical instrument according to embodiment 1,
A stent attached to the metal film,
A medical instrument further comprising:
(12) In the medical instrument according to embodiment 11,
The medical device, wherein the stent is attached to the metal thin film by adhesion.
(13) In the medical instrument according to embodiment 11,
The gluing includes the use of a bonding material.
(14) In the medical instrument according to embodiment 11,
The bonding includes a medical device including heat utilization.
(15) In the medical instrument according to embodiment 11,
Said bonding includes the use of a chemical binder.
(16) In the medical instrument according to embodiment 11,
Said gluing includes the use of mechanical means.
(17) In the medical instrument according to embodiment 11,
The attachment between the stent and the metal film is made by a radial force exerted by the stent along the inner surface of the metal film tube.
(18) In the medical instrument according to embodiment 11,
The stent includes at least one hoop structure extending between a proximal end and a distal end of the stent.
(19) In the medical instrument according to embodiment 17,
The hoop structure is a medical device including a plurality of strut members arranged in the vertical direction and a plurality of loop members connecting adjacent struts.
(20) In a medical instrument for occluding a body vessel,
A thin-film tube that stretches longitudinally to give a smaller peripheral contour by applying mechanical energy, and self-expands to the length and diameter prior to stretching when the mechanical energy is released A thin film tube,
A plurality of holes carved in a wall of the thin film tube, the holes supporting the thin film tube to extend longitudinally; and
A medical device equipped with.
(21) In a medical device for occluding a body vessel,
A thin-film tube that stretches longitudinally to give a smaller peripheral contour by applying mechanical energy, and self-expands to the length and diameter prior to stretching when the mechanical energy is released A thin film tube,
A stent attached to the inner surface of the metal film;
A medical device equipped with.

FIG. 4 shows a perspective view of a medical device in an embodiment of the present invention formed from a deployed or “pre-expanded” shape membrane tube. FIG. 4 shows a perspective view of a medical device in an embodiment of the present invention formed from an elongated contracted profile and a constrained membrane tube. FIG. 4 is a perspective view of a medical device in an embodiment of the present invention, with only a portion of the radial slots along the proximal and distal ends open, with the intermediate radial slot substantially closed. FIG. 1 is a partial cross-sectional perspective view of a medical device deployed in a blood vessel in an embodiment of the present invention. FIG. 1 is a partial cross-sectional perspective view of a medical device in an embodiment of the present invention deployed over an aneurysm in a blood vessel wall, showing the medical device having a proximal stent with a thin film tube attached to the blood vessel wall. FIG. 1 is a partial cross-sectional perspective view of a medical device in an embodiment of the present invention deployed across an aneurysm in a vessel wall, the medical device having a proximal stent with a membrane attached to the vessel wall along the proximal end, and a distal end; FIG. 6 shows a state having a distal stent with a distal end of a thin film attached to a blood vessel wall along the same. 1 is a partial cross-sectional perspective view of a medical device in an embodiment of the present invention deployed across an aneurysm in a blood vessel wall, the medical device having a plurality of hoop portions axially arranged along a longitudinal central axis It is a figure which shows the state provided with. 1 is a longitudinal section in an embodiment of the present invention showing a medical device having a free-standing metal thin film tube loaded into a delivery catheter. 2 is a longitudinal section in an embodiment of the present invention showing a medical device having a self-expanding stent for additional radial support. 2 is a longitudinal section in an embodiment of the present invention showing a medical device having a stent capable of balloon expansion for additional radial support.

Claims (21)

In a medical device for occluding a body vessel,
A thin-film tube that stretches longitudinally to give a smaller peripheral contour by applying mechanical energy, and self-expands to the length and diameter prior to stretching when the mechanical energy is released A thin film tube,
A plurality of slots carved into the wall of the membrane tube that open to assist in extending the membrane tube in a longitudinal direction, the membrane tube being self-extending in length and diameter A slot that closes substantially when expanded, and
A medical device equipped with. The medical instrument according to claim 1,
The thin film tube is a medical instrument formed of a metal thin film exhibiting superelastic characteristics. The medical device according to claim 2,
The metal thin film is a medical instrument formed of a nickel titanium alloy. The medical instrument according to claim 1,
The thin film tube is a medical device formed of a pseudo metal thin film exhibiting superelastic characteristics. The medical instrument according to claim 1,
The thin film tube is a self-supporting medical instrument. The medical instrument according to claim 1,
The thin film tube is a medical device formed as a single layer material. The medical instrument according to claim 1,
The thin-film tube is a medical device formed as a multilayer material. The medical instrument according to claim 1,
The medical instrument, wherein the slot is engraved completely through the wall thickness of the tube. The medical instrument according to claim 1,
The medical instrument, wherein the slot is engraved partially through the wall thickness of the tube. The medical instrument according to claim 1,
A plurality of holes provided in the wall of the tube,
A medical instrument further comprising: The medical instrument according to claim 1,
A stent attached to the metal film,
A medical instrument further comprising: The medical device according to claim 11,
The medical device, wherein the stent is attached to the metal thin film by adhesion. The medical device according to claim 11,
The gluing includes the use of a bonding material. The medical device according to claim 11,
The bonding includes a medical device including heat utilization. The medical device according to claim 11,
Said bonding includes the use of a chemical binder. The medical device according to claim 11,
Said gluing includes the use of mechanical means. The medical device according to claim 11,
The attachment between the stent and the metal film is made by a radial force exerted by the stent along the inner surface of the metal film tube. The medical device according to claim 11,
The stent includes at least one hoop structure extending between a proximal end and a distal end of the stent. The medical device according to claim 17,
The hoop structure is a medical device including a plurality of strut members arranged in the vertical direction and a plurality of loop members connecting adjacent struts. In a medical device for occluding a body vessel,
A thin-film tube that stretches longitudinally to give a smaller peripheral contour by applying mechanical energy, and self-expands to the length and diameter prior to stretching when the mechanical energy is released A thin film tube,
A plurality of holes carved in a wall of the thin film tube, the holes supporting the thin film tube to extend longitudinally; and
A medical device equipped with. In a medical device for occluding a body vessel,
A thin-film tube that stretches longitudinally to give a smaller peripheral contour by applying mechanical energy, and self-expands to the length and diameter prior to stretching when the mechanical energy is released A thin film tube,
A stent attached to the inner surface of the metal film;
A medical device equipped with.

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